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510(k) Data Aggregation

    K Number
    K171435
    Device Name
    VirtuOst Vertebral Fracture Assessment
    Manufacturer
    O.N. Diagnostics, LLC.
    Date Cleared
    2018-08-03

    (445 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    O.N. Diagnostics, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Virtu Ost VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
    Device Description
    VirtuOst Vertebral Fracture Assessment (VFA) software is used to perform vertebral morphometry and is an integrated component of VirtuOst (K113725). VirtuOst VFA accepts as input a sagittal section of a vertebral body, obtained from a spine-containing computed tomography (CT) scan, and provides semi-automated, interactive tools with which the user can perform six-point quantitative vertebral morphometry according to well-established guidelines. The process can be repeated for multiple vertebral bodies. For each vertebral body analyzed, the quantitative vertebral morphometry algorithm locates three points each along the superior and inferior endplate on a sagittal section through the vertebra, typically a mid-sagittal section. The user verifies or modifies point placement. Based on these six morphometry points, anterior, posterior and middle vertebral heights are measured. Percent deformities are calculated from these heights and are then compared against well-established criteria for vertebral deformities typical of osteoporosis-related vertebral fracture in order to classify types and grades of any existing osteoporosis-related vertebral fracture, from which a patient can be classified as being at high risk of a future osteoporosis-related fracture. The VFA algorithm can be applied to any complete vertebral body captured in the CT scan, and the scan can be contrast-enhanced or not. Consistent with the recommended use of the well-established fracture-classification criteria, deformity types and fracture grades and fracture-risk classifications are only reported for vertebral levels T4 through L4. A report is generated containing these results, along with images of the sagittal sections from which the measurements were acquired. A physician then interprets the report to make any medical diagnoses or treatment decisions.
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